Safety and Efficacy in Type 2 Diabetic Patients With Severe Chronic Renal Impairment, 5 mg BI 1356 (Linagliptin) vs. Placebo, Insulin Background Inclusive

Completed · Phase 3 · Has a placebo group

Conditions studied: Diabetes Mellitus, Type 2

In brief

to determine safety, efficacy and tolerability of BI 1356 versus placebo

Key facts

Study ID

NCT00800683

Run by

Boehringer Ingelheim

People needed

133

Starts

2008-12-01

Last updated by the study team

2014-05-20

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male and female patients with type 2 diabetes and with glomerular filtration rate (GFR) <30 ml/min, who are not on chronic dialysis.
• Insufficient glycemic control (hemoglobin A1c (HbA1c) between 7.0% and 10.0%)
• Age 18 or over and not older than 80 years

You may not qualify if…

• Treatment with any other anti diabetic drug other than insulin and/or sulphonylurea within 3 months prior to informed consent
• Myocardial infarction, stroke or transient ischemic attack (TIA) within 6 months prior to informed consent
• Unstable or acute congestive heart failure

Where it is running

• 1218.43.10011 Boehringer Ingelheim Investigational Site — Chula Vista, California, United States
• 1218.43.10006 Boehringer Ingelheim Investigational Site — Riverside, California, United States
• 1218.43.10021 Boehringer Ingelheim Investigational Site — Whittier, California, United States
• 1218.43.10013 Boehringer Ingelheim Investigational Site — Pembroke Pines, Florida, United States
• 1218.43.10009 Boehringer Ingelheim Investigational Site — West Palm Beach, Florida, United States
• 1218.43.10018 Boehringer Ingelheim Investigational Site — Decatur, Georgia, United States
• 1218.43.10022 Boehringer Ingelheim Investigational Site — Chicago, Illinois, United States
• 1218.43.10015 Boehringer Ingelheim Investigational Site — Shreveport, Louisiana, United States
• 1218.43.10016 Boehringer Ingelheim Investigational Site — Kansas City, Missouri, United States
• 1218.43.10003 Boehringer Ingelheim Investigational Site — Great Neck, New York, United States
• 1218.43.10004 Boehringer Ingelheim Investigational Site — The Bronx, New York, United States
• 1218.43.10020 Boehringer Ingelheim Investigational Site — Winston-Salem, North Carolina, United States
• 1218.43.10019 Boehringer Ingelheim Investigational Site — Delaware, Ohio, United States
• 1218.43.10008 Boehringer Ingelheim Investigational Site — Mentor, Ohio, United States
• 1218.43.10005 Boehringer Ingelheim Investigational Site — Bethlehem, Pennsylvania, United States
• 1218.43.10007 Boehringer Ingelheim Investigational Site — Carlisle, Pennsylvania, United States
• 1218.43.10001 Boehringer Ingelheim Investigational Site — Providence, Rhode Island, United States
• 1218.43.10025 Boehringer Ingelheim Investigational Site — Aiken, South Carolina, United States
• 1218.43.10023 Boehringer Ingelheim Investigational Site — Austin, Texas, United States
• 1218.43.10024 Boehringer Ingelheim Investigational Site — Austin, Texas, United States
• 1218.43.10014 Boehringer Ingelheim Investigational Site — Dallas, Texas, United States
• 1218.43.10017 Boehringer Ingelheim Investigational Site — Lufkin, Texas, United States
• 1218.43.10010 Boehringer Ingelheim Investigational Site — Tacoma, Washington, United States
• 1218.43.61009 Boehringer Ingelheim Investigational Site — Gosford, New South Wales, Australia
• 1218.43.10027 Boehringer Ingelheim Investigational Site — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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